NCT02058251

Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In comparison to the general population, military personnel and veterans are at increased risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder (PTSD). Despite promising developments in the past decade, the treatment of patients with SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al., 2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or systemic OT administration decreases activation of the amygdala in response to visual fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little attention has been focused on whether OT decreases SUD vulnerability after exposure to traumatic stress in preclinical or clinical studies. This clinical project will determine whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.

Conditions

• Alcohol Use Disorders

Interventions

Type	Name	Description
DRUG	Oxytocin	One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.
DRUG	Placebo	Each participant will self-administer a 40 IU dose of intranasal saline.

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-01-01
• Completion: 2017-04-01
• First posted: 2014-02-10
• Last updated: 2019-03-14
• Results posted: 2019-03-14

Locations

1 site across 1 country: United States